Amgen Wins, ImClone Loses in FDA Approval Gamble

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Researched by Industrialinfo.com (Industrial Information Resources, Inc; Houston, Texas). With untold millions at stake, drug companies find themselves playing against dreadful odds with each new product in development. Beyond the incredible expense of drug development and the strenuous clinical trial process, manufacturers also have the responsibility to take it to market. Two recent FDA decisions illustrate just what a gamble the entire process is.

Amgen, Inc. (Thousand Oaks, CA) (NasdaqNM:AMGN) chose to lay a wager in the form of over $200 million in manufacturing facilities at their 232-acre Longmont, Colorado campus, years prior to FDA approval of their drug Aranesp, for patients with anemia-related kidney problems. It appears likely to pay off with the potential $5 billion in sales they expect the recently approved Aranesp to help generate.

ImClone Systems, Inc. (New York, NY) (NasdaqNM:IMCL), thinking they had a sure winner in Erbitux, a treatment for colon cancer, invested $40 million at their Branchburg, NJ facility. ImClone wasn't alone in feeling confident in anticipating FDA Approval, as Bristol-Myers Squibb (New York, NY) (NYSE:BMY) invested $1 billion in September of 2001 to secure the drug's U.S. marketing rights.

Since then, the FDA announced on December 28, 2001 that they were rejecting ImClone's Erbitux application, judging the documentation insufficient to properly review the drug, ImClone's shares have fallen drastically from a high of $75.00 on December 6, 2001 to $17.00 on January 18, 2002. The question is, did ImClone attempt to hedge their bet by cutting corners during clinical trials?

ImClone is struggling to survive, battling lawsuits from irate investors, and facing a congressional investigation into allegations that the company deceived those investors. Their newly expanded plant has been idled. If forced to undergo new trials, Erbitux may not be available for months, if ever.

Amgen is riding the wave of success with a second drug, the rheumatoid arthritis therapy Kineret, which recently received FDA Approval. They have announced future plans to expand the Longmont site to 4 million square feet, an expenditure that could reach $500,000,000.

If ImClone is ultimately found not to have played by the rules, then their gamble will prove to be a costly one, both in dollars and the loss of a potential life saving drug, notes Annette Kreuger, Industry Manager of Pharmaceutical-Biotech at Industrialinfo.com. Amgen played their cards right.